This study is ongoing, but not recruiting participants.
Official Title
Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women – The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study
Detailed Description:
The original base protocol was extended. Subjects in the placebo arm of the base study are to be given 3 doses of open-label GARDASIL™ (V501) at Extension Day 1, Extension Month 2 and Extension Month 6. Subjects were followed to Extension Month 7.
A Long Term Follow-Up (LTFU) extension study [(V501-019-20)(NCT00090220)] will observe the long term safety, effectiveness, and immunogenicity of GARDASIL™ in 1,600 women who participated in the base protocol in Colombia . Data will be collected over a period of 6-10 years following subjects’ enrollment in the original base protocol…..
View the entire paper here.
